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Kentucky House Approves Mesothelioma Awareness Day Bill

Wednesday, March 17, 2010

The Kentucky House of Representatives passed Senate Bill 62 designating September 26th of each year as Mesothelioma Awareness Day. The bill as approved on Monday was amended to include an unrelated house bill related to child deaths in the state.

September 26 of each year is designated "Mesothelioma Awareness Day" throughout the Commonwealth. The Governor shall proclaim September 26 of each year as "Mesothelioma Awareness Day" and shall encourage Kentuckians to support research into effective treatments and early detection methods.

Mesothelioma is a rare, aggressive form of cancer primarily caused by exposure to airborne asbestos fibers. Close to 3,000 Americans are diagnosed with the cancer yearly. Most cases of mesothelioma are diagnosed 30 years or more after exposure, with the latency period sometimes as long as 50 years. Although there is no cure for mesothelioma, it can be treated with varying degrees of success through the use of surgical procedures, chemotherapy and radiation.

The Mesothelioma Applied Research Foundation started the initiative in 2005 with a goal to "bring attention to this underfunded, asbestos-related cancer through a national campaign." Last year almost twenty cities and states participated.

Sources:
Bill Passes
Belluck Applauds Bill

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posted by Nancy Meredith at 8:00 AM
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British Lung Foundation Announces 2010 Action Mesothelioma Day

Tuesday, March 16, 2010

The British Lung Foundation, the only UK charity working for people affected by lung disease, has announced their annual Action Mesothelioma Day for July 2, 2010. The goal of the day is to raise awareness of mesothelioma and to improve the care and treatment for patients.

Mesothelioma is a rare, aggressive form of cancer primarily caused by exposure to airborne asbestos fibers. The number of mesothelioma deaths each year in the UK has increased from 153 in 1968 to around 2000 today.

Last year's Day included a variety of events throughout the UK including a parliamentary reception at the House of Commons. The attendees discussed a survey of mesothelioma patients and their caregivers that showed that two-fifths of the patients did not have access to end-of-life care. They also discussed the impact of the Mesothelioma Framework on NHS services.

The British Lung Foundation started Action Mesothelioma Day in 2006 in conjunction with the creation of the Mesothelioma Charter. The Charter calls for improved care and treatment for mesothelioma patients, better protection for employees and more funding for research.

The events for 2010 have not yet been announced.


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Labels: For Your Family, mesothelioma

posted by Nancy Meredith at 8:00 AM
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Asbestos Awareness Week Proposed to Warn About Mesothelioma Danger

Monday, March 15, 2010

To raise awareness of the risks associated with asbestos, known to cause mesothelioma, Senator Baucus of Montana introduced a resolution proposing the first week of April 2010 be set aside as Asbestos Awareness Week. Baucus represents the residents of Montana where nearly 300 people died in Libby from asbestos-related diseases.

Libby, Montana is the site of the W.R. Grace mine and mill that closed in 1980 which is suspected as the site of the asbestos exposure. Often called “asbestos cancer,” mesothelioma is highly aggressive and is resistant to many standard cancer treatments. Currently there is no known cure for mesothelioma, and the average survival time varies from 4 - 18 months after diagnosis.

Senate resolution 427 urges the Surgeon General to warn and educate people about the public health hazard of asbestos exposure. The resolution cites the fact that thousands of workers in the U.S. face significant asbestos exposure as well as the fact that a significant percentage of asbestos disease victims were exposed to asbestos on naval ships and in shipyards while serving the country.

For decades, asbestos was widely used in building materials and insulation. About 3,000 new cases of mesothelioma are diagnosed each year in the United States.

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posted by Nancy Meredith at 8:00 AM
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NIH-FDA Collaboration Could Speed Innovations for Mesothelioma Treatment

Friday, March 12, 2010

by Nancy Meredith
In an effort to speed medical innovations to physicians and their patients, the United States Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have joined forces. The partnership has identified several key areas that could benefit including stem cells for Parkinson’s disease, safer pain medications, and personalized treatment for cancer through the use of markers.

Research is currently underway that could develop biomarkers for any cancer including mesothelioma making way for personalized treatment. Mesothelioma is a rare, aggressive form of cancer primarily caused by exposure to airborne asbestos fibers. There is no known cure for mesothelioma, however, many clinical trials and studies are in progress that could offer hope to mesothelioma patients.

Scientific Disciplines Come Together
Through collaboration the NIH and FDA will be developing initiatves to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients. To support this the agencies will bring together translational science and regulatory science.

Translational science is often referred to as the bench-to-bedside aspect of scientific discovery. This is where the discoveries are translated into practical applications. The scientists begin the process at "the bench" with basic research such as studying disease at the molecular level. They then provide the tools to clinicians to take the innovation to the clinical level or to the patient's bedside. This aspect is the NIH's discipline.

The FDA must then take the information from the translational research and develop policies and regulations that take the medical devices and products to market. Regulatory science is the science and tools used by the FDA and other government agencies to evaluate product safety, efficacy, potency, quality and performance to protect and benefit American citizens.

The agencies will be establishing a Joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The new council will ensure that regulatory considerations become an integral part of biomedical research planning, and that the latest science is integrated into the regulatory review process.

The Health and Human Services Secretary Kathleen Sebelius said that "collaboration between NIH and FDA will go a long way towards fostering access to the safest and most effective therapies for the American people."

Enhancing Regulatory Science and Encouraging Research
According to the FDA report "Speeding Progress to Patients" the development of new therapies has been in decline, and the costs of bringing them to market have soared.

This trend has had a negative impact on the economic health of the U.S. biotechnology industry. The report further states that “American lives are at risk” because the FDA's evaluation methods are not keeping pace with the changes in the drug discovery methodologies.

The NIH-FDA collaboration recognizes that breakthroughs in regulatory science are critical to ensure medical innovations reach the patients in a timely manner. In addition, incentives in the translational field are important.

Currently the FDA offers millions of dollars in grants each year per the U.S. Orphan Drug Act providing financial incentives to bring biological products for rare diseases, such as mesothelioma, to market. Only one drug, Alimta, has been approved as an orphan drug in the treatment of malignant pleural mesothelioma.

The joint team will make $6.75 million available over three years for work in regulatory science. The goal is to provide new methods for the scientific and regulatory communities to better evaluate medical product development.

Saving Lives
"I am confident that our strengthened coordination and collaboration with NIH will enhance our efforts and add important momentum toward achieving our common goals of improving health, reducing disease and saving lives," said Dr. Margaret A. Hamburg, M.D., Commissioner of Food and Drugs.

The FDA and the NIH will hold a public meeting in the spring to solicit input on how the agencies can work better together.

Sources:
NIH-FDA Collaboration
Speeding Progress
Hamburg Remarks



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posted by Nancy Meredith at 8:00 AM
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Rearcher to Study Link Between Mesothelioma and Cell Stress

Thursday, March 11, 2010

Dr. Stefan Marciniak of the University of Cambridge has been awarded funding for a project to study the relationship between cell stress and mesothelioma. The funding is provided by the British Lung Foundation and the June Hancock Mesothelioma Research Fund.

Marciniak and his colleagues have been studying endoplasmic reticulum (ER) dysfunction and the role it plays in many human diseases, including diabetes and cancer. It is critical for him and his researchers to understand the biological processes it provokes, and through this project he hopes to gain a better understanding of why mesothelioma progresses as it does.

Mesothelioma is a rare, aggressive cancer primarily caused by exposure to airborne asbestos fibers. Symptoms of mesothelioma may not appear until up to 50 years after initial exposure to asbestos. However, after symptoms become apparent, mesothelioma often rapidly progresses resulting in life-threatening complications.

The study will look at proteins produced by ER. Marciniak has shown that when ER proteins accumulate the cell is said to experience "ER stress," which is increased in mesothelioma cells. The researchers hope to assess whether the amount of ER stress on cells can predict the speed at which mesothelioma develops. This will in turn help determine the success of mesothelioma treatments including chemotherapy.

Upon receiving the grant Dr. Stefan Marciniak said,"I hope to be able to take my findings out of the laboratory to improve the treatments available to my patients in the future." Mesothelioma is highly aggressive and is resistant to many standard cancer treatments. Currently there is no known cure for mesothelioma.


Marciniak Receives Grant


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Labels: mesothelioma, Research News

posted by Nancy Meredith at 8:00 AM
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Predicting Post-Surgery Survival for Mesothelioma Patients

Wednesday, March 10, 2010

Results from a new study indicate that an RNA molecule found in cancerous tissue may be useful in predicting a mesothelioma patient’s chances for survival after surgery. The researchers reported in Cancer Research that the presence of even one specific microRNA has significant predictive value for determining the course that mesothelioma will take after surgery.

Mesothelioma, an unusual form of cancer caused by exposure to airborne asbestos fibers, often has a complex growth pattern making complete surgical removal a difficult task. The goal of the surgery is to achieve a macroscopically-complete resection, which refers to the removal of all visible tumor cells. This type of test will give doctors another tool to identify post-surgical treatment for patients including chemotherapy or radiation.

MicroRNAs play a key role in biological processes, such as development, cell proliferation and apoptosis (the process of cell death). Thus, altered microRNA is likely to contribute to cancer and other diseases. MicroRNAs have been used as prognostic markers for numerous forms of cancer and as biomarkers to pinpoint the tissue where cancer originated. But few studies have explored the role of microRNAs in malignant pleural mesothelioma.

“Mesothelioma is a terrible disease, and this specific microRNA may help doctors and clinicians give patients and their families a more accurate prognosis of the disease and how post-surgical patients will likely respond,” said attorney Joseph W. Belluck. “It’s an important step in understanding and combating this disease.”

Belluck, a partner in the law firm Belluck & Fox, said the research represented a potential breakthrough in helping guide treatment of mesothelioma patients.

The research was supported in part by philanthropic grants from the law firm of Belluck & Fox, LLP in New York and the Stephen Banner Lung Cancer Foundation.

Full Story




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Labels: mesothelioma, Research News

posted by Nancy Meredith at 7:48 AM
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9-11 Responders Have Access to Mesothelioma-Causing Asbestos Health Screening Tests

Tuesday, March 9, 2010

In February the Asbestos, Lead & Hazardous Waste Laborers' local union 78 placed a coffin on the streets of New York to draw attention to the health hazards associated with asbestos, and to the fact that asbestos has been linked to deadly diseases. This serves as a reminder that people that work around asbestos, or have been exposed to it, should carefully monitor their health for signs of mesothelioma or other asbestos-related diseases.

Many workers at New York's shipyards, powerhouses, plants and construction sites were exposed to asbestos. In addition, Ground Zero workers , especially those who were first on the scene, may be at risk for developing mesothelioma and other asbestos-related diseases in the coming years.

Asbestos is a known carcinogen and is linked to mesothelioma. Often called "asbestos cancer," mesothelioma is highly aggressive and is resistant to many
standard cancer treatments. When the towers collapsed, asbestos and other toxic substances such as mercury and lead were released into the air. Medical researchers are now seeing unusually high incidences of respiratory issues and lung scarring in the workers.

The National Institute for Occupational Safety & Health (NIOSH), in an effort to protect and treat 9-11 responders, are offering free health exams for volunteers or paid responders to the World Trade Center attack. The World Trade Center Medical Monitoring examinations are provided free-of-charge.

The tests consist of the following:

• Physical examination by a doctor


• Routine blood and urine tests (no drug or HIV testing)


• Breathing tests


• Interview by doctor or nurse about medical history


• Mental health questionnaire


• Questionnaire about occupational exposures


• Referral for treatment, if necessary


• Advice on Workers’ Compensation and other benefit programs, if necessary

According to the NIOSH website, there are three reasons for which they encourage participation in the screenings. 1) The program will follow participants health for a five-year period, and provide longer-term medical monitoring if resources become available. 2) Not all conditions cause symptoms, so by getting periodic examinations, it may be possible to detect any late-starting diseases. 3) The information that will be gained by following the group of 9/11 workers and volunteers will be extremely valuable in understanding how to protect worker health in future emergencies.

People who qualify include rescue and recovery workers, clean-up workers, anyone who performed essential restoration services, morgue personnel, and those who worked on the Fresh Kills landfill and barges.

See http://www.wtcexams.org/ for eligibility requirements, and for additional information.



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Labels: mesothelioma

posted by Nancy Meredith at 8:00 AM
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Researchers Have Breakthrough in Development of Mesothelioma Vaccine

Monday, March 8, 2010

Reasearchers in the Netherlands, using a special type of cell known as a dendritic cell that is a key regulator in the immune system, have created an immunotherapy treatment against mesothelioma. They hope the research will one day lead to a vaccine for people who have been exposed to asbestos to help prevent asbestos-related diseases.

Mesothelioma is a rare form of cancer typically affecting the lining of the lungs. Primarily caused by exposure to airborne asbestos fibers, most cases of mesothelioma are diagnosed 30 years or more after exposure. The latency period can be as long as 50 years.

Immunotherapy uses the body's own immune system to target and destroy cancer cells. The aim of immunotherapy is to harness the strength of the immune system in a specifically focused attack on cancer cells, while avoiding the broader toxic effects of chemotherapy.

The researchers tested the vaccine on 10 patients achieving 80 percent effectiveness. The results generated an immune T-cell response against the mesothelioma tumors. T-cells assist other white blood cells in immunologic processes. Treatment is a series of three vaccinations given over a two week period after receiving chemotherapy.

“This is the first human study on dendritic cell-based immunotherapy in patients with mesothelioma,” said Dr. Joachim Aerts, a pulmonary physician at Erasmus Medical Center in the Netherlands and lead author of a study published online in the American Thoracic Society’s Journal of Respiratory and Critical Care Medicine.

While the size of the study was small, the researchers said the results suggest that selected patients may benefit from dendritic cell immunotherapy without major adverse effects.



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Labels: mesothelioma, Research News

posted by Nancy Meredith at 7:20 AM
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Mesothelioma: One of Over 6,000 Orphan Diseases

Friday, March 5, 2010

by Nancy Meredith
In the United States an "orphan disease" status is assigned to a disease or disorder if it affects fewer than 200,000 Americans at any given time. The Food and Drug Administration estimates that today there are over 6,000 rare diseases affecting more than 25 million people. According to the National Organization for Rare Disorders (NORD), 1 out of 10 Americans have a rare disease.

Mesothelioma is an aggressive form of cancer primarily caused by exposure to airborne asbestos fibers that is diagnosed in 3,000 Americans each year. Mesothelioma shares the orphan disease distinction with other well-known diseases including colon cancer, multiple sclerosis, AIDS, and cerebral palsy. Between 85 and 90 percent of the orphan diseases are serious or life-threatening.

1983 Orphan Drug Act
Many of these diseases afflict so few people that researchers and pharmaceutical companies do not find it beneficial to expend the time, effort or money to find treatments and cures. As a result foundations and organizations were formed to fund grants to entice researchers to dedicate resources to "their" disease, or to advocate Congress for support.

NORD was established in 1983 by patients and families who encouraged the U.S. government to take action towards supporting researchers in focusing on rare diseases such as mesothelioma.

In 1983 Congress passed the U.S. Orphan Drug Act offering financial incentives to help companies recover the cost of developing a drug for small patient populations. Orphan drug designation, which is intended to facilitate drug development, provides substantial potential benefits to the sponsor, including funding for certain clinical studies, study-design assistance, and several years of market exclusivity for the product upon regulatory approval.


The Office of Orphan Products
The Office of Orphan Products Development (OOPD), under the direction of the FDA, is dedicated to promoting and advancing the development of products (drugs, biologics, medical devices, and medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.

In addition, the office is to provide coordination among Federal, other public, and private agencies in carrying out their respective functions relating to the development of products for rare diseases or disorders.

According to the FY2010 OOPD Budget Report the Orphan Drug Act, and the operation of the program, has been successful. As of April 21, 2009, 339 drugs and biological products for rare diseases have been brought to market. In comparison, only 10 such designated products had been approved in the 10 years prior to the 1983 act.

Orphan Drug Grants
The OOPD also funds the Research Grants Program. The goal of the grant program is to encourage clinical development of products for use in rare diseases or conditions. The FY2010 budget for orphan product grants is $14,315,864.

Orphan product grants successfully fosters and encourages the development of effective medical products for the treatment and cure of rare diseases. The recipients of the grants are able to focus on product development in a compressed time period with a very modest investment. OOPD grant funding is typically offered for up to three years for Phase 1 trials, and up to four years for Phase 2 and 3 trials.

In addition, the Department of Defense awarded several million dollars for three important mesothelioma projects. The funds will support research into early detection of the disease and the development of new treatments, including clinical trials for a promising new vaccine that will directly impact patients.

Orphan Drug Designation
Only one drug has been APPROVED as an orphan drug in the treatment of mesothelioma. Pemetrexed Disodium (Alimta) was designated on February 28, 2001, with an exclusivity start date of February 4, 2004, for the treatment of malignant pleural mesothelioma. Specifically the approved orphan indication is for treatment of patients with malignant pleural mesothelioma whose disease is either unresectable or who are otherwise not candidates for curative surgery.

The following drugs hold the Orphan Drug designation status for the treatment of malignant mesothelioma, but have not yet been approved.

• 5,6-Dihydro-5-Azacytidine from ILEX Oncology, Inc, designated 5-11-1992


• Arenegyr from MolMed S.p.A. (Italian), designated 08-22-2008


• Aroplatin from Antigenics Incorporated, designated 09-01-1999


• Onconase from Alfacell Corporation, designated 01-25-2007


• Ss1(Dsfv)-Pe38 from National Institutes of Health Cancer Therapy Evaluation Program, designated 02-11-2002


• Vorinostat from Merck & Co., Inc., designated 03-17-2004

Coordination with European Medicines Agency (EMA)
On March 1, the U.S. FDA and the EMA announced they will coordinate on orphan drug designations through acceptance of a single annual report from sponsors of orphan drugs and biologic products designated by both the United States and the European Union. Prior to this agreement, drug sponsors had to submit separate reports.

Both agencies, as well as sponsors, will benefit from the single report. The report will contain a full set of data pertaining to an orphan drug including information on the ongoing clinical studies, a description of the investigation plan for the coming year and information on anticipated or current problems.

The single annual report submission to both regulatory agencies is voluntary and will apply only to sponsors who have obtained an orphan designation status for their product from both the FDA and EMA.



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posted by Nancy Meredith at 7:16 AM
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New Test May Determine if Mesothelioma is Gone

Thursday, March 4, 2010

Researchers from Johns Hopkins have created a test that can identify if and when a tumor is coming back after a patient has undergone initial treatment. Blood tests are compared with the unique genetic cancer sequences from the original tumor to tell whether surgeons removed all of the cancerous cells, whether the cancer has spread to other parts of the body, or whether the cancer is coming back. Called the PARE approach, researchers believe the test could be used to develop biomarkers for any cancer including mesothelioma.

Mesothelioma, an unusual form of cancer caused by exposure to airborne asbestos fibers, often has a complex growth pattern making complete surgical removal a very difficult task. The goal of the surgery is to achieve a macroscopically-complete resection, which refers to the removal of all visible tumor cells. Finding hidden cells can be close to impossible making a test like this critical to the treatment of both pleural mesothelioma and peritoneal mesothelioma.

Led by Victor E. Velculescu, MD, PhD, the team found that each patient's cancer is unique, which is the key to this new test that may revolutionize cancer treatment. The team identified nine unique tumor characteristic rearrangements at the ends of its chromosomes that together serve as the tumor's fingerprint. PARE is named for this finding: personalized analysis of rearranged ends.

This test is not yet widely available and the cost, around $5,000 per patient, may be prohibitive to some. Johns Hopkins University holds the patent on PARE.

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Labels: mesothelioma, treatments

posted by Nancy Meredith at 8:04 AM
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